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As we all know, when the 2009 H1N1 (swine flu) influenza started spreading across the globe, a lot of preparation took place to stop it from spreading, yet it still did. The World Health Organization declared it a pandemic in June 11, 2009. Luckily, the toll in human lives of this pandemic was quite mild, given our worst expectations. That is a good thing, especially for the anti-vaccine advocates who have jumped at the opportunity to blame anyone and everyone involved in the preparation and prevention efforts of fear mongering. “You told us a lot of people could get sick and die; that didn’t happen therefore you lied to us, to fill your pockets with cash” is how the general argument goes. The words may not be the exact ones you’ll hear, but that is the sentiment in a nut shell.

The link she provides takes you to this web page. Clearly, Dorey agrees with the article, otherwise she wouldn’t have linked to it as she did. Thus, she must agree with the following from the article:

Our health officials still insist on describing the swine flu (H1N1) as a pandemic – even though the UK’s health supremo admitted this week that just 70 people died from the infection, forgetting that he had predicted 750,000 deaths.

Of course, swine flu was never a pandemic even though the World Health Organization (WHO) classified it as such in 2009, and regulators and researchers the world over have perpetuated the myth.

Before the pandemic classification, drug companies had got purchase agreements out of governments around the world that were triggered the moment a pandemic was announced. GlaxoSmithKline made $698m in extra sales from its Pandemrix swine-flu shot alone.

Let us distill the above “argument” so we can analyze it and see if it is a good argument or nonsense. Basically they, and Dorey by endorsement, are saying that because number of deaths from swine flu was low, this was not a pandemic, and also throw in the “Big Pharma made money” line to imply that the reason the WHO declared the 2009 H1N1 as a pandemic was to increase profits for Big Pharma. That money argument is so baseless in and of itself that doesn’t deserve to be addressed. Anyone willing to start and end the conversation at “someone made money therefore we were lied to” is immune (pun intended) to reason and logic.

In order to see through the incredibly ridiculous argument that Dorey & Friends are making, we need to understand what a pandemic is. What does it mean for a disease to “go pandemic”? The answer is simple: pandemic refers to an infectious disease that has spread a lot, geographically. So you need two components to have a pandemic: 1) an infectious disease, which swine flu is, that 2) has spread to a lot of countries/continents, which swine flu did.

Pandemic does not refer to numbers of people infected, number of deaths, or the rate at which the disease kills. It refers to how widespread geographically the disease becomes. That’s it. You don’t have to believe me. Here (page 11) is the table of the six phases of a pandemic, as defined by the WHO.

CLICK TO SEE CLEARER VERSION

It is clear to anyone who can, and is willing, to read and comprehend the English language that pandemic refers to geographical spread of the disease and has nothing to do with mortality. Nowhere in that table is mortality mentioned. It simply is not part of the equation, so far as the definition of the word pandemic is concerned.

Which brings us to the question: Why then are the anti-vaccine advocates pretending that there was no pandemic? There are only a few reasons this would happen that I can think of:

They are ignorant of the meaning of the word “pandemic”

They have no research skills, and are unable to do a Google search to find out the meaning of the word “pandemic”

They are fully aware of the meaning of the word “pandemic” but still make the bad argument, while knowing it to be without merit, which is a questionable practice to say the least

They could care less about the facts and will say anything their agenda demands

A combination of the above

Regardless of the reason why they got it so wrong, how much trust can we have in them if they cannot even get these simple things right? How can we rely on them to provide us with real, true information for more complex issues, if they screw up so bad with simple ones? The only way, the anti-vaccine front can say that the 2009 H1N1 pandemic was not a pandemic is by showing evidence that it didn’t spread worldwide and was contained within two countries in one WHO region. They cannot do that; the facts are not on their side. As of the last count, the 2009 H1N1 had spread to more than 214 countries worldwide.

The conspiracy article Dorey gladly and mindlessly linked to ends up with this:

This is the most cases reported in 60 years when 6,613 cases were reported in 1950, and the highest incidence in 51 years when a rate of 16.1 cases/100,000 was reported in 1959.

154 (58%) of hospitalized cases were infants ❤ months of age, and 201 (75%) were infants <6 months of age.

153 (76%) of the hospitalized infants <6 months of age with known race and ethnicity were Hispanic.

10 deaths have been reported; 9 (90%) were Hispanic infants. Nine fatalities were infants <2 months of age at time of disease onset and had not received any doses of pertussis-containing vaccine;the 10th victim was an ex-28 week preemie that was 2 months of age and had received the first dose of DTaP only 15 days prior to disease onset.

Rates are highest in infants <6 months of age (317.2 cases/100,000), in children aged 7-9 years (46.8 cases/100,000) and children aged 6 months-6 years (38.4 cases/100,000)

A new study, published online at The Lancet shows that the bivalent polio vaccine, which is currently in use in India and Nigeria and offers protection against two of the polio virus strains, type 1 & 3, triggers a stronger immune response than the existing trivalent vaccine and similar immune response to the monovalent vaccines.

Study Summary – This was a double-blind, randomized, controlled study which enrolled 830 babies in India, between August and December 2008. The researchers compared various oral polio vaccines’ efficacy in inducing an immune response, measured by the number of antibodies created after the doses were received (seroconversion). The total amount of antibodies was measured and compared after the first dose, and also after a second dose.

The babies were set up in 5 groups; it is not clear from the summary but it appears that each group would have received one of the following vaccines:

monovalent type 1

monovalent type 2

monovalent type 3

bivalent 1 & 3

trivalent.

Although it is possible that some group may have been given a combination of monovalent vaccines; I am not sure. What does mono, bi, trivalent mean? It means this: the monovalent vaccines protect against one type only of the virus that causes polio. For example, monovalent type 1 protects against the Type 1 of the polio virus. Bivalent vaccines protect against two types at the same time, and trivalent vaccine protects against 3 types at the same time.

Immune response, or seroconversion, was measured after the first dose, and after the second dose of the vaccines. The responses were compared for the various vaccines.

Results – The results were as such:

Seroconversion after Dose 1

Type 1 Virus

Monovalent – 20%

Bivalent – 20%

Trivalent – 15%

Type 2 Virus

Monovalent – 21%

Bivalent – N/A

Trivalent – 25%

Type 3 Virus

Monovalent – 12%

Bivalent – 7%

Trivalent – 4%

Seroconversion after Dose 2 (cumulative)

Type 1 Virus

Monovalent – 90%

Bivalent – 86%

Trivalent – 63%

Type 2 Virus

Monovalent – 90%

Bivalent – N/A

Trivalent – 91%

Type 3 Virus

Monovalent – 84%

Bivalent – 74%

Trivalent – 52%

The vaccines were well tolerated. 19 serious adverse events occurred, including one death; however, these events were not attributed to the trial interventions.

Conclusion – This study shows statistically significant differences between the bivalent and the trivalent vaccine, differences that become clearer after the second dose, at which point the bivalent vaccine outscored the trivalent one by more than 20% points for both polio viruses Type 1 and 2. There are no statistically significant differences between the bivalent and monovalent vaccines.

The conclusion following the results of this study is that, in this study the bivalent vaccine worked better than the trivalent vaccine in inducing an immune response, in infants. Further, the bivalent vaccine rates of seroconversion was just as good as the monovalent vaccines ones.

It is important to keep in mind though, that this study was only measuring the immune response, and does not draw any conclusions about the reduction of polio infections, hospitalizations or death rates. If that was the goal of the study, a proper placebo control would be absolutely necessary, but given that the purpose of the study was to compare efficacy of seroconversion rates as compared to the trivalent/monovalent vaccines, the use of a placebo is not necessary, since it is logical to assume that any placebo effects would similarly affect all groups of participants.

As such this study, in and off itself, does not lead to any conclusions about the bivalent vaccine’s efficacy in preventing polio infections, hospitalizations and deaths. We may extrapolate given it’s seroconversion rates, and what it is known about the monovalent/trivalent vaccines effects on polio infections/hospitalizations/death rates, but that would be just that, an extrapolation. The only question this study directly answers is: How does the bivalent polio vaccine compare to the monovalent and trivalent polio vaccines in inducing an immune response?

The authors concluded as such:

The findings show the superiority of bOPV compared with tOPV, and the non-inferiority of bOPV compared with mOPV1 and mOPV3.

What happened – Raymond Plotkin, was a freshman at the University of New Mexico. He was studying to become an engineer. He started class in August 2009 as a freshman interested in Chemical and Nuclear Engineering. He enjoyed his roommates and living in a dorm as part of the Engineering Living Learning Community. In 2009 he had the regular flu shot, but due to shortages of the vaccine, he wasn’t able to get the H1N1 vaccine.

While Raymond had health issues growing up, he had no problems in the last couple of years, according to family members. Doctors told the family they do not believe underlying health problems contributed to his death

He died on Wednesday evening of November 11, 2009, four days after being admitted in the hospital. Said Raymond’s mother:

“It was a terrible tragedy. It could have been prevented had there been vaccine,”

“We are strongly recommending that because Raymond couldn’t take his shot last year, that this year everyone, that whether you’re a child, adult, parent, grandparent, we all take one for Raymond,”

People are getting complacent about H1N1. Please remember what happened to Raymond and get both the seasonal flu and H1N1 vaccines as soon as you can.

Raymond’s family has set up a scholarship fund in honor of Raymond’s memory. The first scholarship was awarded to Sean Chavez, a 2010 graduate of Albuquerque High School and computer engineering student at UNM.

For more information about the fund, please contact Susan Georgia, UNM School of Engineering Development Office at 505 – 277-0664; sgeorgia@​unm.​edu.

Not that this will settle anything, because science fact is not decided by arguments from popularity, but I think it is important to point this out. Many in the anti-vaccine community appeal to a “mommy knows best” argument, in which they will tell a very emotional story about how a mother saw their child fade away right after getting a vaccine. McCarthy herself has told her son’s story many times, telling us how she, to paraphrase, saw his soul fade away right after the vaccine. The implication is that mothers of autistic children know that their children’s autism is caused by vaccines.

Nevertheless, surveys do not support this notion. A survey of 62 families of autistic children found out that only 29% of parents of autistic children blame vaccines for their children’s autism (page 6). So if mothers know best, it appears McCarthy is in the minority within the community of parents of autistic children. It appears, at least from this survey, that about 70% of parents of autistic children do not blame vaccines for their children’s autism. So if the results of this survey hold, and can be extrapolated out to the entire population of parents of autistic children, which is quite a stretch to be honest, it would appear that for every mommy instinct blaming vaccines, there are two mommy instinct not blaming vaccines.

So what does this mean for the vaccines-autism “controversy”. Absolutely nothing; the correlation, or lack there of, between vaccines and autism is a scientific issue, not a popularity contest. The fact is what it is, regardless of what parents think, and I’m willing to say that even when parental opinion is on my side. Is Jenny McCarthy, and all the rest in the anti-vaccine community, willing to do the same? The answer to that question would shed so much light on their ability, and willingness, to find out the truth.

It is reasonable to ask how new vaccines are tested before they are cleared for public use. The National Institute of Allergy and Infectious Diseases explains the various studies that must be done before the new vaccine is approved by the FDA. There are various stages of testing a vaccine must undergo before it is cleared for use. They are as follows.

1) Animal Testing– Firstly, the new vaccine is tested in animals for safety and immunogenicity, meaning that is must be safe and induce enough of an immune response to justify moving on with human trials.

2) Phase I Study – After a promising animal test, the process moves to what is referred to as clinical trials, meaning testing in human subjects. The first step in this process is a Phase I study, which is the first setting in which an experimental vaccine is given to people. The trial, which can last up to 2 years, may enroll between 20 to 100 volunteers. A Phase I study primarily seeks information on safety, particularly looking for any vaccine-related side effects. The study can also provide data on the dose and administration schedule needed to achieve the optimal immune responses.

3) Phase II Study – Once Phase I studies show the experimental vaccine is safe, well tolerated, and appears promising, it can advance into Phase II. These studies, which can last longer than 2 years, enroll between 100 to 300 volunteers. In these studies researchers gather more data on safety and immunogenicity. These studies also test the effects of varying the doses, and are also referred to as dose-ranging studies.

4) Phase III Study– The most promising vaccine candidates move into Phase III, enrolling 10,000 or more people. A Phase III study, which can last up to 4 years, is typically designed to ensure enough data are collected on safety and effectiveness to support a license application to FDA.

An intermediary study, called a Phase IIb study is being considered, as a middle step between the Phase II and the Phase III studies. This study would enroll between 2,000 and 9,000 volunteers. It appears, as of the time of writing, that Phase IIb studies are not a requirement like the others.

Besides the required tests, the FDA may require additional testing and data at any point. Furthermore, the proposed manufacturing facility undergoes a pre-approval inspection during which production of the vaccine as it is in progress is examined in detail. Vaccine approval also requires the provision of adequate product labeling to allow health care providers to understand the vaccine’s proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public.

Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 studies-formal studies on a vaccine once it is on the market. Also, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins. The VAERS system and how it works is discussed further on this website.